Tuesday, February 14, 2012

Bioethicists and Conflicts of Interest

I write this post with some trepidation because the issue is still evolving. However, I have been committed to the idea that those of us in bioethics should be willing to subject ourselves to the same scrutiny that we apply to others, and so feel a need to walk the walk even at risk of being premature. Plus I invite comments from my fellow bioethicists to this post and maybe the comments will prove more illuminating than the post.

The latest flap in our bioethics neck of the woods has to do with the editorship of the American Journal of Bioethics and the doings of the recent editor-in-chief, Glenn McGee, PhD. According to various of my colleagues, Dr. McGee is either a) an unethical bioethicist and should be roundly condemned or b) the victim of scurrilous character assassination.

Briefly, Dr. McGee was originally on the faculty at Art Caplan's prestigious bioethics program at Penn, but left when he failed to get tenure there--not necessarily a black mark as I doubt Aristotle would be granted tenure at Penn. He then became director of the bioethics institute at Albany Medical College, but left there under a cloud--lest I be accused of more character assassination I'll let the Scientific American do it instead:http://www.scientificamerican.com/article.cfm?id=glenn-mcgee

The above-cited article quotes Dr. McGee as saying, "I am going to be entering a new phase of my career in which I am a dartboard." Dartboard or no, he next landed at the Center for Practical Bioethics in Kansas City where he held the John B. Francis Chair--not a terribly severe demotion, it would seem. All this time he continued to act as editor of AJOB, which he founded, and spun off two new AJOB journals, including one called AJOB Primary Research.

The controversy gets going sometime late in 2011 when Dr. McGee apparently left the Center in Kansas City to take up a position with a firm called Celltex in Sugar Land, outside Houston. Celltex is a very controversial outfit down in these parts, storing and injecting adult stem cells taken from a person's fat cells, a process which has not been FDA approved but endorsed by legislation that Gov. Rick Perry pushed through the Texas Legislature after he reportedly had a dramatic response to these injections for his back pain. Celltex is run by Gov. Perry's physician and a former Perry political ally. Dr. McGee was first listed as President of Strategic Initiatives at Celltex while a more recent news release (http://www.scribd.com/doc/81588050/February-10-2012-Celltex-Press-Release) has him as President of Ethics and Strategic Initiatives.

Now, I have to add a prequel here--a Korean firm, RNL Bio, involved in the stem cell tourism industry, had two patients die after receiving their stem cell infusions. A US group called the International Cellular Medicine Society investigated in November 2010. Dr. McGee was then on the ICMS board of directors and conducted a bioethics inquiry, which, according to Carl Elliott in one of the above posts, "found little fault with RNL Bio; he recommended better informed consent procedures and more ethics training." Now, Celltex has a close relationship with RNL Bio, having paid them a reported $30M to license their stem cell procedure. If I were to issue an "ethics" report that said Firm X was on the up and up, and then shortly after took a job with Firm Y which relies on a relationship with Firm X to be able to market its main product, then you would have reasons to be suspicious of biasin my "ethics" report, it would appear to me.

After complaints surfaced that it was inappropriate for Dr. McGee to remain as editor while working for a for-profit stem cell firm, he stepped down as editor while apparently remaining as head of the "AJOB family of journals" for the publisher, Taylor and Francis. The new co-editors of AJOB are Dr. David Magnus of Stanford, an old colleague of Dr. McGee's from Penn days, and Dr. Summer Johnson McGee, formerly managing editor of the journal, and incidentally, Mrs. Glenn McGee.

The fact that Dr. McGee retains his position as head of all the AJOB journals is significant because the Primary Research journal is now edited by Robert Nelson, a bioethicist and pediatrician. Dr. Nelson works at the FDA and is in the division that would review any application for approval of the adult stem cell treatments that Celltex promotes. So you could say that Dr. McGee is the boss of the guy at the FDA who might end up approving or disapproving his company's product.

That'a the anti-McGee case and critics are calling for the remainder of the editorial board of AJOB to at least meet and demand an acocunting of these measures if not resign en masse in protest.

On the other side, it's been pointed out (mostly on listservs where I don't have permission to copy the entries) that the editorial board is supposed to advise the editor on editorial policy, not advise the publisher on hiring and firing of editors, so it's not the job of the editorial board to decide who should or should not be editor of AJOB. Dr. McGee, it has been said, noted a potential conflict of interest and managed it appropriately by resigning as editor. His wife, as a long-time central figure in the day-to-day running of the journal, is very well qualified to assume a role as co-editor, and it's sexist and patronizing to view her as a mere appendage of her husband for this purpose.

Dr. Leigh Turner of U-Minnesota, in the post cited at the beginning, accuses Dr. McGee of scrubbing the Internet to alter the records of when he was in what position, to obfuscate the fact that he was involved in these conflicts of interest. As I review the instances he cites, the majority of these look more like updating rather than "scrubbing." But the one instance where this charge seems to hold water is with the most recent Celltex news release. That makes it seem that Dr. McGee had left his previous posts before assuming his role with Celltex, whereas it appears that there was at least a few months' overlap. As Dr. Turner alleges, the intent of the news release seems to be to appear to backdate his resignation as editor of the journal.

If anyone is still reading after all this, I will hesitantly offer some opinions.

I am not sure that the charge of conflict of interest can stick at this point with regard to the editorship of AJOB. The argument that there was a conflict, and Dr. McGee resolved same by resigning, seems reasonable. Normally when one transfers ownership of something to one's spouse, it's a transparent mechanism of trying to remain within a conflict while pretending to resolve the conflict; but the argument that Dr. Summer McGee has valid reasons to assume editorship in her own right seems plausible. The charge of COI seems to stick however with regard to Dr. McGee's role in naming Dr. Nelson to be editor of the other journal, and remaining in a position to oversee him as editor, when Dr. Nelson has a role at the FDA that could involve Celltex's interests.

I wonder if my bioethics colleagues, who are ordinarily very good at making fine ethical distinctions, are actually conflating two separate issues:

Is it a COI for Dr. McGee to edit AJOB?

Is it seemly for a bioethicist to work for Celltex?

I have just given my reasons to be skeptical of the first; what about the second? I spent some time looking for information on how Celltex markets its services--perhaps significantly, I was unable to locate a company website. If you read the news release, Dr. McGee says that the company is completely legit, they tell everyone that adult stem cell treatments are experimental, and all procedures have IRB approval. But various press reports (for example, http://houston.culturemap.com/newsdetail/12-26-11-nations-largest-stem-cell-lab-opens-in-sugar-land/) show Celtex marketing its wares and making a hefty bundle upfront; and a blog from a Celltex patient indicates that at least one recipient is sure she's getting real therapy and is immensely grateful to the fine people who are treating her disease: http://debbiebertrand.blogspot.com/2012/02/best-offering.html

My personal opinion is that it is highly unseemly and embarrassing for the field of bioethics to have one of our own working for this sort of firm, and giving ethical "cover" to their activities. It appears that contrary to the claim that their activities are highly ethical and are fully disclosed as experimental only, Celltex is seeking to make profits by presenting what it does to the public as effective therapy. There seems ton be a conflict of interest within the firm if the news release is to be taken seriously and Dr. McGee is actually charged with creating a true ethics program within the company. If he were to succeed in fully informing all patients that this is an unproven, experimental "treatment," it would seem to seriously cut into any chance of the company recouping the $30M they paid RNL Bio for the stem cell license. So one has reason to doubt that the firm is serious about their "ethicist" and his activities.

I explained in HOOKED that I agree with Ed Erde that the core ethical issue at the heart of conflict of interest is trust in a social role. "Bioethicist" is a social role and all of us have a stake in making the role as trustworthy as possible in the public eye. It seems to me that what Dr. McGee is doing with Celltex is predictably going to diminish trust in our field. (For evidence that this is already happening see http://leiterreports.typepad.com/blog/2012/02/american-journal-of-bioethics-redux-is-this-for-real.html).

So my current advice to my bioethics colleagues, based on what I have learned so far, is: if you think that Dr. McGee is a discredit to bioethics, talk about his role with Celltex. If on the other hand you think he's a fine fellow unfairly besmirched, then defend his role with Celltex. But forget about the side issue of the AJOB editorship which is just a distraction in my view. Now, bioethicists, have at me and send your comments.

NOTE ADDED 2/18/12: Off line, I have been taken to task for my attempted witticism regarding getting tenure at Penn. It was pointed out to me that a number of distinguished people in bioethics were in fact granted tenure there, and I apologize if my ill-timed humor seemed to cast an aspersion on that university.

NOTE ADDED 2/27/12: Dr. David Magnus, one of the co-editors of AJOB, has asked me to correct misinformation in the main post above: "You suggest that even though Glenn stepped down as EIC of AJOB, he retains his position as "head" of all three journals. This is not the case. Glenn has no role regarding the content of any of the three journals (and in fact never had any such role for AJOB Primary Research). Robert "Skip" Nelson has his own contract with Taylor and Francis and has no reporting line to Summer and me or to Glenn or to anyone other than Taylor and Francis. The relationship between the three journals relates to how they are marketed, sold (they are bundled in institutional subscriptions), and some shared management regarding Manuscript Central and Scholar One. And to be very clear, Glenn's resignation included discontinuing any role at all in the running and management of the AJOB family of journals." My apologies for any erroneous information I may have conveyed.

NOTE ADDED 3/6/12: I had the pleasure of speaking with Dr. Robert “Skip” Nelson, editor of AJOB Primary Research. Dr. Nelson clarified his role at the FDA. He functions as a pediatric ethicist and advises various centers within the FDA about ethical issues in pediatric research. He has no authority to issue any rulings with regard to the approval of any therapy. Again, I apologize for anything I may have said in the original post that gave an incorrect impression. Dr. Nelson also informed me that his role at the journal has been clarified by naming him “editor-in-chief,” to show that the three AJOB journals actually all function independently of each other editorially.

12 comments:

Howard, I believe the AJOB issue is still relevant. I concur with you that it's not the ed board's role to determine who is editor. However, Glenn McGee still has a conflict of interest here. First, as you note, his overseeing the "AJOB family of journals" means that Nelson will have a close association with someone whose products he will be asked to evaluate in his capacity at the FDA. Second, I don't think it's sexism to suggest that McGee turning over the editorship to Summer McGee fails to resolve Glenn McGee's conflict of interest. I would maintain that the conflict of interest would persist if Summer McGee were Glenn McGee's same sex partner! No one's suggesting she's a "mere appendage" or is unqualified. The COI is that Summer McGee stands to benefit financially if AJOB were to publish articles favorable to CellTex-style stem cell therapy. And if Summer McGee benefits financially, then — not so wild stab in the dark here — Glenn McGee benefits as well. Both have a COI here.

For these reasons, I'd like to see the ed board take a strong stand here: indicate their intention to dissociate themselves from AJOB by resigning unless a new editor without such obvious COI's is named.

Michael, I agree with your point about Summer McGee's COI around articles specifically related to stem cells--and due to space limits I did not mention that the current agreement among the editors seems to be that she'd disengage from any editorial review of such articles. You can decide if that's enough, or not-- thanks, Howard

Howard,I don't think it would be enough for Summer McGee to recuse herself only from issues directly related to stem cells. As your post suggests, she would also have to recuse herself from a host of other issues, including, but not limited to: research ethics, conflicts of interest, relationships between industry and academia, innovative therapy, FDA regulation, patient deaths in clinical trials, research standards in other countries, and cozy relationships between biotech companies and state governments, all of which have direct financial implications for the new editor-in-chief and the ongoing “founding editor.” When I asked David Magnus, the Co-Editor-in-Chief, what the policies would be for deciding when an Editor would or would not recuse, he gave me this: " Editors will recuse themselves from any involvement in decisions where they have a financial or other conflicting interest.” In other words: "Don't ask. Trust us." I don't. I've resigned from the AJOB editorial board. I will no longer submit papers to AJOB. I will no longer cite papers published there.

The whole thing makes me sad, because AJOB has been a great journal, it has taken years to build, and the current leaders have, in my opinion, carelessly and needlessly destroyed a valuable resource.

I think that, in addition to the distinction you make (between the editorship & Celltex), we ought to make another distinction, namely that between Celltex in particular and industry in general. It's hard not to suspect that -- for many bioethicists anyway -- much of the horror at this story is a knee-jerk reaction to the involvement of any form of private industry. Celltex seems to be a particularly problematic firm. But historically bioethicists are severely allergic to industry in any form; in some cases, that leads away from thoughtful reflection on complex issues.

Thanks to everyone who has posted so far. John Lantos makes excellent points and illuminates things that I probably failed to in my main post. I said that the core ethical idea behind COI is trust in a social role. One way to destroy such trust is to act in ways that violate the main tenets of one's professional responsibility. If one is involved in a firm that seems to be engaged in ethically questionable behavior (specifically, overstating the therapeutic benefits of an unproven treatment), and one proclaims that one is doing so in one's role as a bioethicist, this could predictably cause public trust in bioethics to deteriorate. Whether one's behavior then also conforms to the specific criteria for a COI is rather beside the point, or at least seems to me a secondary point, though I see the validity of many of the further comments made about COI. The important point is that COI is one but not the only way to destroy trust in a social role.Chris MacDonald is correct that some of us in the field have an allergic reaction to throwing one's lot in with for-profit industry. I plead guilty. Hence my efforts to be very specific in what I see as the problem with Celltex. However I would also add that regular readers of this blog have seen some reasons why I suffer from my allergy. The track record of bioethics engagement in business has not been a uniformly happy one in my view. See the Xigris case in HOOKED for a specific example. Nevertheless I hope that some day before I die, bioethics along with other stakeholders will find a suitably neutral turf on which to engage with the pharmaceutical industry toward the emergence of a new, integrity-preserving relationship between medicine and Pharma--and do so without the bioethicists making themselves rich off the process.

My reactions are an amalgam of Howard's and John's. I feel really sad about the whole thing because (and here is where I agree with Howard) it is a violation of trust. When I read what Brian Leiter wrote on the Leiter Report, it both saddened and angered me that our field is being dragged into the mud as a result of this series of questionable decisions. I don't care whether or not Glenn goes to work for a corporate entity, but I do care that what bioethics stands for is being called into question along with it.

John Lantos (Feb. 16, 2012 4:05 AM): I’ve resigned from the AJOB editorial board. I will no longer submit papers to AJOB. I will no longer cite papers published there.

Dr. Lantos,

I disagree with your intention to no long cite papers published in AJOB. Authors have a scholarly duty to reference their work accurately. Deliberately not doing so might constitute an ethical infraction.

After dumping on clinical trial subjects (The Guinea Pigs, Chapter 1); medical writers (The Ghosts, Chapter 2); pharmaceutical company sales representatives (The Detail Men, Chapter 3), opinion leaders in the pay of pharmaceutical companies (The Thought Leaders, Chapter 4), pharmaceutical company marketing to the public (The Flacks, (Chapter 5), Carl Elliott, in his book, White Coat, Black Hat: Adventures on the Dark Side of Medicine saves the worst for last: The Ethicists (Chapter 6).

I hope Dr Lantos will reconsider his intention to never cite papers published in AJOB. I'm an untenured (but tenture-track) bioethicist, and I have been published in AJOB. I -- and the rest of us pursuing tenure and working to establish ourselves in the field -- stand to be hurt when our work is excluded not on its own merits (or lack thereof) but in an overly zealous effort to shun a journal. There are no COIs in my little paper about the death penalty. I will certainly think about whether I want to have my work appear in AJOB while this ethical cloud hangs over the journal, but the many AJOB authors who are completely on the up and up do not deserve to be shunned because of something allegedly done by the McGees.

To SJohnson: I also found it a bit over the top to refuse to cite previous AJOB papers; but I also must admit to bias due to having published several papers in AJOB myself--including a major paper on conflicts of interest!

Dr. Brody, you said that: " the core ethical idea behind COI is trust in a social role. One way to destroy such trust is to act in ways that violate the main tenets of one's professional responsibility."

This, I think, is what is behind much of the story here. Dr. McGee and Dr. Johnson McGee have already violated many people's "trust in a social role" due to the controversy and fall-out that happened at Albany Medical Center/the Alden March Bioethics Institute. And while that was dragged through the internet, and all sides came off looking poorly, it seemed that the final outcome of it was "we'll agree to disagree and move on."

Dr. McGee, however, was apparently aware that he was going to be a punching bag, dartboard, or otherwise target after the 'misstep' at AMC/AMBI. Most folks, when faced with that knowledge, would work especially hard to regain and maintain the trust of everyone who ended up violated by that action.

By apparently having no regard whatsoever for that, other than taking on a victim's mantle, and by violating the trust of his colleagues once again, Dr. McGee seems to be moving into "fool me once, shame on you, fool me twice, shame on me" territory. What reason does anyone have to accept his declarations of conflict-of-interest, management of AJOB, etc, when it looks like the last two months have been full of conflicts of interest? (And depending on apparently what press release what day, the next few months will be, as well.)

Unfortunately for Dr. Johnson McGee, by virtue of her marriage, she is being judged with this - and that she did not say "stop" or "no" or "this is wrong" at any point.

Were this the first time their integrity was being questioned, we might simply see something similar to what played out in Scientific American in the summer of 2008. But taken together as a pattern, it creates a disturbing trend that requires more than "just trust me" from two people who have not done anything to earn, let alone maintain, trust.

As to be expected, Howard defines the issues clearly. I am less worried than some as to how & whether the McGee & Co issue will tarnish the work of bioethics. Millions of people in NA & through-out the world have benefitted & continue to benefit from medical ethics. Are people going to retreat from the contributions (consent, truthtelling etc) ethics has helped to make to medicine on account of this imbroglio? Years ago, McGee at al might have gotten away with their overweening ambition but not now. We have higher standards and will judge those who fail to meet them. This debate is an exhibition of good ethics at work and not a demonstration of its imminent failure.